Varicose vein treatment showdown: foam vs. heat
NCT ID NCT05312970
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared two treatments for varicose veins: Varithena (a foam) and Endothermal Ablation (using heat). It included 43 adults with a faulty great saphenous vein. The goal was to see which treatment better reduced symptoms like heaviness and pain over 3 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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43 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Apr 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 * Primary GSV incompetence, defined as reflux \> 0.5 seconds on Duplex ultrasound in a single limb (Note the contralateral limb can have varicosities or SVI if intervention is not required within 3 months i.e. asymptomatic) * Failed conservative therapy (compression, diet, exercise, leg elevation) * CEAP Clinical Condition Classification C2 - C6 * Vein diameter 5-10mm, inclusive * GSV treatable length \> 10cm * Superficial venous disease manifest by clinical symptoms (rVCSS ≥ 4) * Able to comprehend and sign an informed consent document and complete written study questionnaires * Willing and able to return for scheduled follow-up visits (7-days, 3-months, 6-months, 12-months, 24-months, and 36-months post-procedure) * Willingness to comply with post-treatment compression protocol Exclusion Criteria: * Allergy to polidocanol, xylocaine, or epinephrine * Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization or hypercoagulable disorder * Post thrombotic deep vein disease above the calf veins * Pregnancy or lactating (within 30 days of randomization) * Symptomatic peripheral arterial disease or ankle-brachial pressure index (ABPI) \< 0.8 * Previous treatment to targeted incompetent GSV or previous superficial thrombophlebitis in targeted GSV * Previous venous intervention in affected limb in past 3 months * Local aneurysmal GSV segments * Inability to walk unaided * Inability to wear post-procedure compression bandaging and stockings * Patients with clinically significant reflux of the small saphenous vein (SSV) or anterior accessory saphenous vein (AASV) * In the clinical judgement of the investigator, patient who will require ipsilateral deep venous intervention within 3 months following randomized treatment * In the clinical judgement of the investigator, patient who will require contralateral venous intervention (superficial or deep) within 3 months following randomized treatment * Patient on therapeutic anticoagulants * Active malignancy * Life expectancy \< 2 years * Documented COVID-19 infection currently or within 2 months prior to randomization * Enrollment in another clinical trial that could confound the endpoint within 3 months prior to screening or within 3 months following enrollment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
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Columbia University Medical Center
New York, New York, 10032, United States
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Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
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Lake Washington Vascular
Bellevue, Washington, 98004, United States
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Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20057, United States
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Stony Brook University Hospital
Stony Brook, New York, 11794, United States
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UT Physicians Cardiothoracic and Vascular Surgery
Houston, Texas, 77030, United States
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Vascular Care Connecticut
Darien, Connecticut, 06820, United States
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Vein Healthcare Center
South Portland, Maine, 04106, United States
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Other studies related to the condition(s) this trial covers.
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